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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
510(k) Number K261837
Device Name FINDER Flu A&B/SARS-CoV-2 Test
Applicant
Baebies, Inc.
25 Alexandria Way,
Durham,  NC  27703
Applicant Contact Vijay Srinivasan
Correspondent
Baebies, Inc.
25 Alexandria Way,
Durham,  NC  27703
Correspondent Contact Vijay Srinivasan
Regulation Number866.3981
Classification Product Code
QOF  
Date Received06/02/2026
Decision Date 09/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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